Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit
FDA 510(k) clearance K212204 · decided 2021-08-11
Clearance details
- K-number
- K212204
- Device name
- Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit
- Applicant
- Cd Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-07-15
- Decision date
- 2021-08-11
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- QGN
- Device class
- 2
- Regulation number
- 866.3230
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Claymont, DE, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cd Diagnostics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.